Our client is developing small molecule precision medicines for the treatment of neurological and psychiatric disorders. They are seeking a Regulatory Strategy Director who can develop and implement regulatory strategies for a late-stage program. Reporting into the VP of Regulatory Affairs, you will work closely with cross-functional teams and interact directly with Health Authorities. This company offers a strong development pipeline, innovative science, and excellent funding. With two programs going into Phase 3 global trials, now is an exciting time to join this growing organization!
Responsibilities:
- Create and implement innovative and effective regulatory strategies to support the development of global drug development programs, including a Phase 3 epilepsy program.
- Provide regulatory expertise and advice to cross-functional team members including clinical, CMC, clinical pharmacology, and nonclinical.
- Serve as the regulatory lead on project teams.
- Represent the company as the point of contact for FDA and other regulatory health authorities.
- Maintenance of regulatory applications such as INDs, CTAs, NDAs, etc.
- Identify regulatory risks and mitigation plans.
- Ensure compliance with local and international submission requirements.
- Manage CROs as applicable.
- Ensure exemplary ethics and transparency within the company and with health authorities.
- Keep current with global regulatory landscape and advise project teams on potential impact to programs
- Provide mentorship and support to junior team members to foster their professional growth and development.
Qualifications:
- Bachelor degree in life sciences required. Advanced degree such as MS, PhD, or Pharm D preferred.
- 12 or more years of experience in the pharmaceutical or biotech industry with 10+ years in clinical Regulatory Affairs.
- Experience with neurology/CNS programs and small molecules preferred, but not required.
- Must be able to develop regulatory strategies and also do more tactical hands-on execution.
- Late-stage/Phase 3 experience highly desired.
- Experience working with DAAP or Neurology FDA Divisions is desired, but not required.
- Must have Global drug development experience including EU/EMA.
- Experience working on a major marketing application (NDA/BLA/MAA) a plus.
- Ability to manage competing priorities, influence and integrate within a team, manage timelines and deliver on corporate and program goals.
- Strong interpersonal skills and alignment with the company’s values and company culture
- Must demonstrate strong leadership and team building skills, including experience with conflict resolution and real time problem solving.
- Thorough understanding of the development phases within a fast-moving biopharmaceutical organization.
- Exceptional written and verbal communication skills.
- Must be flexible and comfortable with ambiguity in a fast-paced, small company environment.
NOTE: This hybrid role is based in Boston MA. Local employees must be onsite in the office three days a week; those outside of the Boston area must be onsite once per quarter. East Coast candidates are highly preferred.
The budgeted salary range for this position is $220,000 to $240,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.